Hundreds of Medical Devices & Accessories - 3 DHF's?

A

Anoniem

#1
Goodmorning!

Thank you for all the help this forum gave me. I need some direction, hopefully somebody can help me with this:

We develop and manufacture medical devices; class 1 (EU) class2 (USA). Since we start to export to the USA, I would like to reorganize the DHF's.

We have about 500 sellingcodes, all different configurations of- or accessories to the parent medical devices. These can be divided into 3 groups with each their own intended use. So I was planning to create 3 main DHF's which include the most complex and risk full devices, the parent devices. (about 30) I can include the requirements, risk analysis, verification, validation etc for those devices.

But how can I prove a FDA auditor that we planned and controlled the design of the other configurations and accessories? An excel list with references?

Thank you for your support!
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Moderator
#2
Re: Hundreds of devices & accessories, 3 DHF's?

Generally speaking, I don't see a problem with dividing your product range into 3 families and creating 1 DHF for each. However, if your design control documentation is not complete (some devices design / development is not covered by the existing docs) it might be a problem. Most US class II devices need design control, regardless of whether you consider them low-risk or not complex.
 
Q

QA-Man

#3
Re: Hundreds of devices & accessories, 3 DHF's?

If you're reorganizing your documents (or doing anything that's not routine) make a Quality Plan that describes the purpose, scope, responsibilities, milestones, etc. Hold some meetings to review things and update your plan.

This way if you're questioned on the reorganization you can demonstrate that you ensured the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented - (bold an italic text copied from ISO 13485 2003 definition of QMS Planning)
 

rwend07

Involved In Discussions
#4
Re: Hundreds of devices & accessories, 3 DHF's?

Generally speaking, I don't see a problem with dividing your product range into 3 families and creating 1 DHF for each. However, if your design control documentation is not complete (some devices design / development is not covered by the existing docs) it might be a problem. Most US class II devices need design control, regardless of whether you consider them low-risk or not complex.
Going along with this, although accessories generally fall into the same category as the parent device, if the accessories are clearly a different device that could fall into class I, it may be worth leaving them out of the main DHF's and have them listed under a Class I classification as they would not then need design controls. This would only work if they clearly fit into a listing other than the parent device that is in Class I.
 

Ronen E

Problem Solver
Moderator
#5
Re: Hundreds of devices & accessories, 3 DHF's?

Going along with this, although accessories generally fall into the same category as the parent device, if the accessories are clearly a different device that could fall into class I, it may be worth leaving them out of the main DHF's and have them listed under a Class I classification as they would not then need design controls. This would only work if they clearly fit into a listing other than the parent device that is in Class I.
Not all class I devices are exempt from Design Control, so it needs to be verified for each case.
 

rwend07

Involved In Discussions
#6
Re: Hundreds of devices & accessories, 3 DHF's?

Not all class I devices are exempt from Design Control, so it needs to be verified for each case.
Correct, sorry for the confusion. I would say that if a part is a minor accessory to a parent device it is unlikely to fall into one of the categories of Class I that requires design control though. Either way, it's worth considering.
 
Thread starter Similar threads Forum Replies Date
M Hundreds of Processes! How to simplify ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
R REACH and ROHS compliance for hundreds of parts made over 25 years REACH and RoHS Conversations 3
P REACH - A few of the hundreds components in my product no longer meet requirement REACH and RoHS Conversations 2
M How to validate hundreds or even thousands of parts? Qualification and Validation (including 21 CFR Part 11) 7
M Simplifying Supplier Evaluations for hundreds of Suppliers Supplier Quality Assurance and other Supplier Issues 6
P GR&R on automated test system which produces hundreds of results Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
J Annual PPAPs - Keeping Up with Hundreds Of Customers And Hundreds Of Part Numbers APQP and PPAP 12
Marc Plane Delay Leaves Hundreds Whiney Travel - Hotels, Motels, Planes and Trains 0
Marc Days After Worker Buyouts, GM to Cut Hundreds of Salaried Jobs World News 4
Marc McAfee Update Breaks Hundreds Of Apps After Work and Weekend Discussion Topics 3
M MDSAP Medical devices Supplyers Canada Medical Device Regulations 1
C. Tejeda Process validation of rework assembly methods (medical devices) Medical Device and FDA Regulations and Standards News 2
B FDA regulations medical device prescription fulfillment DME question US Medical Device Regulations 0
K What are the differences between the certificates required for home and medical medical equipment? US Food and Drug Administration (FDA) 1
N FDA medical devices US Food and Drug Administration (FDA) 1
J Medical Device Manufacturing Manufacturing and Related Processes 3
BusyBee GIVD codes for In-vitro medical devices EU Medical Device Regulations 2
J0anne How to find Certifying Bodies for US based & sold Medical Devices? US Medical Device Regulations 11
T Monolithic medical application ISO 13485:2016 - Medical Device Quality Management Systems 1
Newbie22 UPDATE UKCA; UK 12 month extension (Future regulation of medical devices - extension of standstil period) UK Medical Device Regulations 4
M An introductory guide to medical device Clinical Evaluation & Clinical Evaluation Reports (CER) EU Medical Device Regulations 0
O Regarding design and development requirements for a medical device EU Medical Device Regulations 6
U Leakage test Standard for Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
E Tablet integrated into medical device IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
Ed Panek Is this a medical device? US Medical Device Regulations 2
S Local (country) registration of medical devices - Who does it in best case? Other Medical Device Regulations World-Wide 2
P Medical device testing lab/service standard Other Medical Device Related Standards 1
G Labeling requirements for REFURBISHED medical devices EU Medical Device Regulations 0
L Selling medical devices from USA in EU markets CE Marking (Conformité Européene) / CB Scheme 1
K Medical Device file and "Component" Manufacturers? Other Medical Device and Orthopedic Related Topics 6
rob3027 ISO 13485 justification for design and development exclusion for medical packaging ISO 13485:2016 - Medical Device Quality Management Systems 18
A Class 2b medical device - best pathway to obtain CE mark? (2022, MDR 2017/745) CE Marking (Conformité Européene) / CB Scheme 2
H Active Implantable Medical Devices - ISO 14708 and EN 45502 Other Medical Device Related Standards 0
C Statistics/sampling plan for medical device Inspection, Prints (Drawings), Testing, Sampling and Related Topics 10
A Non-medical device testing in the medical system IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
J Regulatory path to enter EU market for non medical 60601 component Other Medical Device Regulations World-Wide 2
S Training in D&D for engineers with no medical device experience Design and Development of Products and Processes 8
M Software as Medical Device import activities for Chile and Mexico Other Medical Device Regulations World-Wide 0
M Medical Device Indications for Use Health Canada Canada Medical Device Regulations 6
dgrainger Informational Draft for comment - "reclassification of products without an intended medical purpose" EU Medical Device Regulations 6
J Average number of Nonconformances during internal quality audit for Medical Device Manufacturers Internal Auditing 3
D Exclusion 4.2.3 Medical Device File ISO 13485:2016 - Medical Device Quality Management Systems 5
M Lifetime of medical device EU Medical Device Regulations 16
M UDI IVD Medical Device Class III US Food and Drug Administration (FDA) 1
E How to risk assess tooling? For a medical device and is it needed??? Manufacturing and Related Processes 2
P Definition of "Standalone" medical device Other Medical Device Regulations World-Wide 5
B Spare parts of medical device need CE mark? EU Medical Device Regulations 0
R EU MDR Article 22 applicability of medical device with components. EU Medical Device Regulations 4
M Medical Device AE Reporting SOP Medical Device and FDA Regulations and Standards News 0
M Class Exempt Medical Device Recall Question US Food and Drug Administration (FDA) 3

Similar threads

Top Bottom